Overview

AMTSOL is supporting a pharmaceutical manufacturing project in Singapore and is seeking an HVAC CQV Engineer to execute commissioning, qualification, and validation of HVAC systems and Grade C/D cleanrooms in line with EU GMP Annex 1, ISO 14644, and site quality requirements.


Key Responsibilities

• Develop, review, and execute HVAC and cleanroom qualification protocols, including IQ, OQ, PQ, requalification, discrepancy records, and final reports.
• Perform qualification of AHUs, HVAC systems, ducting, controls, HEPA filtration systems, temperature, humidity, differential-pressure controls, and Grade C/D cleanrooms.
• Plan, execute, and review cleanroom certification testing, including airflow visualisation/smoke studies, air-velocity measurements, air-change calculations, HEPA filter integrity testing, non-viable particle monitoring, room pressurisation verification, and temperature/humidity mapping.
• Support FAT, SAT, commissioning, start-up, system balancing, punch-list management, and handover activities.
• Review vendor and contractor documentation, test evidence, calibration records, and turnover packages.
• Manage deviations, change controls, punch-list items, risk assessments, and qualification actions through closure.
• Coordinate with QA, Engineering, Operations, Automation, Facilities, contractors, and validation teams to achieve project milestones.
• Support verification of EMS/BMS monitoring and HVAC automation controls where they form part of the qualified system.
• Maintain accurate, inspection-ready documentation in accordance with GMP and Good Documentation Practices.

Requirements

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Building Services, or a related discipline.
• Minimum 5 years of HVAC and cleanroom CQV experience within pharmaceutical or biotechnology facilities.
• Strong knowledge of EU GMP Annex 1, ISO 14644 cleanroom standards, ISPE Baseline Guides, and Good Documentation Practices.
• Hands-on experience with cleanroom qualification testing, HVAC control verification, deviations, and qualification reporting.
• Strong technical writing, troubleshooting, planning, and stakeholder-management skills.

Preferred / Advantageous

• Experience with sterile manufacturing or aseptic-processing environments, including isolators.
• Experience leading cleanroom qualification or requalification programmes.
• Familiarity with EMS/BMS systems and HVAC automation controls.